Mechanical Ventilation, Ventilator-associated Conditions, ARDS
Conditions
Brief summary
Early mechanical ventilation, if delivered with injurious settings, can lead to pulmonary complications, such as acute respiratory distress syndrome (ARDS). Mechanical ventilation in the emergency department (ED) has been studied infrequently when compared to the intensive care unit; however, data suggests that ED-based mechanical ventilation has significant room for improvement and may also be a causative factor in ARDS incidence.
Detailed description
This is a before-after study examining the impact of implementing lung protective ventilation in the emergency department.
Interventions
PROCEDURElung protective ventilation
Lung protective ventilation strategy, which aims to deliver safe tidal volumes, appropriate PEEP, limit plateau pressure, and limit hyperoxia.
Sponsors
Washington University School of Medicine
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* mechanically ventilated via an endotracheal tube in the ED
Exclusion criteria
* death in the ED, * death or discontinuation of ventilation within 24 hours, * chronic mechanical ventilation, * ARDS while in the ED * transfer to another hospital.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients That Experience Pulmonary Complications After Admission From the Emergency Department | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of Patients That Die During the Hospitalization | Patients will be followed for the duration of hospital stay |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pre-intervention Group mechanically ventilated patients before implementation of ED lung protective ventilation | 1,192 |
| Intervention Group mechanically ventilated patients after implementation of ED lung protective ventilation
lung protective ventilation: Lung protective ventilation strategy, which aims to deliver safe tidal volumes, appropriate PEEP, limit plateau pressure, and limit hyperoxia. | 513 |
| Total | 1,705 |
Baseline characteristics
| Characteristic | Intervention Group | Pre-intervention Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 156 Participants | 438 Participants | 594 Participants |
| Age, Categorical Between 18 and 65 years | 357 Participants | 754 Participants | 1111 Participants |
| Age, Continuous | 58.0 years STANDARD_DEVIATION 24 | 60.4 years STANDARD_DEVIATION 21.1 | 58.8 years STANDARD_DEVIATION 16.9 |
| Region of Enrollment United States | 513 participants | 1192 participants | 1705 participants |
| Sex: Female, Male Female | 210 Participants | 564 Participants | 774 Participants |
| Sex: Female, Male Male | 303 Participants | 628 Participants | 931 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1,192 | 0 / 513 |
| serious Total, serious adverse events | 0 / 1,192 | 0 / 513 |
Outcome results
Primary
Number of Patients That Experience Pulmonary Complications After Admission From the Emergency Department
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pre-intervention Group | Number of Patients That Experience Pulmonary Complications After Admission From the Emergency Department | 171 participants |
| Intervention Group | Number of Patients That Experience Pulmonary Complications After Admission From the Emergency Department | 38 participants |
Secondary
Number of Patients That Die During the Hospitalization
Time frame: Patients will be followed for the duration of hospital stay
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pre-intervention Group | Number of Patients That Die During the Hospitalization | 338 participants |
| Intervention Group | Number of Patients That Die During the Hospitalization | 105 participants |